Public health experts are expressing growing concern that anti-vaccine sentiments, particularly within state and federal governments, may disrupt the approval of new and innovative vaccines currently waiting for FDA authorization in the U.S. These vaccines, which include cutting-edge technologies, might face delays or even fail to reach the public due to rising political opposition.
Just last week, the FDA postponed its decision on Novavax’s COVID-19 vaccine, which had been on track for full approval. Although available under emergency use authorization since 2022, the delay has left experts puzzled. A source familiar with the matter told us that the FDA is seeking additional data before making its decision. This marks the first COVID-19 vaccine review under the Biden administration.
The unexpected delay has raised concerns for other vaccines in the pipeline, such as Moderna’s next-generation COVID-19 vaccine, mRNA-1283, which is slated for an FDA decision by May 31. Additionally, Moderna is seeking approval for its combined flu and COVID-19 vaccine, mRNA-1083, which, if authorized, would be the first vaccine in the U.S. to protect against both flu and COVID-19 in a single shot.
The Search for More Effective Vaccines
Every year, seasonal flu and COVID-19 vaccines are recommended during the respiratory virus season in the fall and winter. While these vaccines can be administered together, they come in separate formulations. Vaccine manufacturers have been working on creating combination shots to simplify and streamline the vaccination process.
Moderna aims to offer a comprehensive solution, providing vaccines for flu, COVID-19, and combination shots as soon as they are approved, according to Dr. Rituparna Das, the company’s vice president of respiratory development.
In June, Moderna released promising trial results showing that its combo vaccine, mRNA-1083, was not only safe but also triggered stronger immune responses against both the flu and COVID-19 compared to existing vaccines, especially in adults aged 50 and older. The hope is that this vaccine could improve protection against these two major respiratory viruses, which have caused significant challenges for healthcare systems in recent years.
Combination vaccines, like the MMR (measles, mumps, rubella) and DTaP (diphtheria, tetanus, and pertussis) vaccines, are already standard in pediatric care, demonstrating the feasibility of multi-disease shots.
Moderna isn’t alone in this effort. Pfizer and BioNTech have also teamed up to develop a flu and COVID-19 combination vaccine using mRNA technology. Novavax is pursuing a protein-based alternative and has indicated plans to find a partner to continue research and development.
“We see a clear demand for combination vaccines, with more than 60% of consumers expressing interest in an all-in-one option,” said Silvia Taylor, a senior executive at Novavax.
However, the future of these combination vaccines may be uncertain, as growing concerns about regulatory delays are mounting, particularly given the experience with Novavax’s COVID-19 vaccine.
Political Attacks on mRNA Technology
Unlike Novavax’s protein-based vaccine, both Moderna’s mRNA-1283 and the flu-COVID combo shots being developed by Moderna and Pfizer/BioNTech use mRNA technology. This method leverages messenger RNA to instruct cells to produce proteins that prompt the immune system to fight viruses like the flu and coronavirus.
While mRNA vaccines have proven safe and effective, concerns are increasing, particularly as political opposition to this technology gains momentum. Some state legislatures are considering bills to ban mRNA vaccines, fueled by misinformation about their safety. Anti-vaccine groups have falsely claimed that mRNA vaccines alter DNA or cause severe side effects.
Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials, expressed concerns that such legislation could prevent access to not just the flu-COVID combo vaccine, but to all vaccines. “We are creating an environment ripe for these kinds of measures to be adopted, which could lead to lower vaccination rates and the spread of infectious diseases,” she warned.
Dr. Peter Hotez, a vaccine expert at Texas Children’s Hospital, also pointed out that political attacks on mRNA vaccines are gaining traction in various state legislatures. Several states, including Montana, Iowa, and Texas, have introduced or are considering bills to restrict or ban mRNA vaccines.
At the federal level, the Trump administration has indicated plans to review mRNA research for transparency. Additionally, Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, who was instrumental in authorizing mRNA vaccines during the pandemic, was recently pushed out of his position.
The Impact of Misinformation on Research and Development
The push to ban mRNA technology is largely driven by misunderstandings about its safety and efficacy, according to Jenna Sexton, a spokesperson for Moderna. “While mRNA does not alter DNA, this misconception fuels harmful policies that could block critical medical advancements,” she stated. If these legislative measures pass, they could delay promising research and limit access to innovative treatments.
Experts like Dr. Dan Barouch of Beth Israel Deaconess Medical Center believe that clearer communication from the scientific community is needed to address public concerns and combat misinformation. “Banning an entire technology because of concerns about a single product is an extreme move,” Barouch said, stressing the broader applications of mRNA, including its potential for cancer therapies and gene editing.
Dr. Amesh Adalja from the Johns Hopkins Center for Health Security noted that anti-vaccine sentiment is not limited to mRNA vaccines. He pointed out that vaccine hesitancy has extended to other vaccine types, such as the Johnson & Johnson and Novavax vaccines, both of which have been available but failed to see widespread use.
The Potential of a Flu-COVID Combo Shot
If approved, a flu-COVID combination vaccine could significantly improve vaccination rates, according to Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center. “Getting both vaccines in one shot could make the process more convenient and increase protection,” he said.
However, Schaffner cautioned that even with approval, it may take time for these combination vaccines to reach the public, as they would first need to be licensed by the FDA and recommended by the CDC for use during the seasonal vaccination campaign.
Vaccine experts argue that mRNA technology could speed up vaccine development, particularly for flu vaccines. “Unlike traditional flu vaccines, which are developed months in advance, mRNA allows for quicker adaptation to the most current flu strains,” Dr. Hotez explained. This could reduce the time required to match flu vaccines with circulating strains and improve overall vaccine efficacy.
In the future, mRNA technology might revolutionize the way we approach seasonal vaccines, offering faster updates and more targeted protection against flu and COVID-19. However, the growing political opposition to this technology could delay these potential breakthroughs.
